AquigenBio Advances Oncology Research with High-Purity Gefitinib and Certified Impurity Standards Including EP Impurity A, B, C, and 4-Desfluoro Impurity HCl to Support Regulatory Compliance and Quality Control

Pune, India - May 9, 2025 - AquigenBio, a leading provider of high-quality impurity standards, is proud to announce the expansion of its product portfolio with the addition of certified impurity standards for Gefitinib. These standards are essential for the pharmaceutical industry, particularly for developers of generic formulations, to ensure the safety, efficacy, and regulatory compliance of their products.

Introduction to Gefitinib and Its Importance in Oncology

https://aquigenbio.com/products/impurity-standards/gefitinib/

Gefitinib, marketed under the brand name Iressa, is an oral medication used in the treatment of non-small cell lung cancer (NSCLC) and other malignancies characterized by mutations in the epidermal growth factor receptor (EGFR). As a tyrosine kinase inhibitor, Gefitinib works by blocking the signals that tell cancer cells to grow and divide. However, the presence of impurities in pharmaceutical formulations can impact the drug's efficacy, safety, and regulatory compliance. Therefore, the identification and quantification of these impurities are essential for ensuring the quality and consistency of Gefitinib products.

The Role of Impurity Standards in Pharmaceutical Development

Impurity standards are critical for various stages of pharmaceutical development, including:
Analytical Method Development and Validation: Ensuring that analytical methods are capable of detecting and quantifying impurities at required levels.

Quality Control and Assurance: Monitoring impurity levels in drug products to ensure they are within acceptable limits.

Regulatory Compliance: Providing necessary data for regulatory submissions to demonstrate that the drug product meets quality standards.

Stability Studies: Assessing the stability of drug products under various conditions to predict shelf life and storage requirements.

AquigenBio's Gefitinib impurity standards are designed to meet the requirements of various pharmacopoeias, including the European Pharmacopoeia (EP) and the United States Pharmacopeia (USP), ensuring that pharmaceutical companies can rely on these standards for their analytical needs.

Overview of AquigenBio's Gefitinib Impurity Standards

AquigenBio offers a range of Gefitinib impurity standards, each serving specific purposes in analytical testing and quality control. These standards are critical for method development, validation, and routine quality assurance testing.

Gefitinib EP Impurity A
https://aquigenbio.com/product/gefitinib-ep-impurity-a/
Chemical Name: 7-Methoxy-6-[3-(morpholin-4-yl)propoxy]quinazolin-4(3H)-one
CAS Number: 199327-61-2
Molecular Formula: C16H21N3O4
Molecular Weight: 319.4 g/mol

Description: This impurity is a known degradation product of Gefitinib and is used as a reference standard for analytical purposes.

Gefitinib EP Impurity B
https://aquigenbio.com/product/gefitinib-ep-impurity-b/
Chemical Name: N-(4-Chloro-3-fluorophenyl)-7-methoxy-6-(3-morpholinopropoxy)quinazolin-4-amine
CAS Number: 1603814-04-5
Molecular Formula: C22H24ClFN4O3
Molecular Weight: 446.9 g/mol

Description: Impurity B is another degradation product that can form during the synthesis or storage of Gefitinib.

Gefitinib EP Impurity C
Chemical Name: 3-Chloro-4-fluorophenylamine
CAS Number: 367-21-5
Molecular Formula: C6H4ClFN
Molecular Weight: 145.56 g/mol

Description: This impurity is a potential by-product from the synthesis of Gefitinib and is relevant for quality control testing.

Gefitinib 4-Desfluoro Impurity HCl
https://aquigenbio.com/product/gefitinib-4-desfluoro-impurity-hcl/
Chemical Name: N-(3-Chlorophenyl)-7-methoxy-6-(3-morpholinopropoxy)quinazolin-4-amine hydrochloride
CAS Number: Not Available
Molecular Formula: C22H25ClN4O3·HCl
Molecular Weight: 428.9 g/mol

Description: This impurity is a hydrochloride salt form of a Gefitinib degradation product and is used in analytical applications.

Applications of Gefitinib Impurity Standards
The availability of high-purity impurity standards is vital for:
Method Development: Establishing and optimizing analytical methods for impurity detection.

Method Validation: Ensuring that analytical methods are suitable for their intended purpose.

Quality Control: Monitoring impurity levels in Gefitinib batches to ensure compliance with regulatory standards.

Stability Studies: Assessing the stability of Gefitinib formulations under various conditions.

Regulatory Submissions: Providing necessary data for regulatory filings, including Abbreviated New Drug Applications (ANDAs).

Regulatory Compliance and Quality Assurance
Compliance with pharmacopeial standards is essential for market authorization. AquigenBio's impurity standards are designed to meet the requirements of various pharmacopoeias, including the EP and USP. These standards are accompanied by comprehensive documentation, including Certificates of Analysis (COA) and Safety Data Sheets (SDS), to support regulatory submissions and audits.
Conclusion
The characterization and control of impurities in Gefitinib

Contact:
Aquigen Bio Sciences
281/1, Plot No 41,
Hinjawadi - Pirangut Rd,
Kasar Amboli, Pirangut,
Pune, Maharashtra 412108
Phone: +91 7030123794
Email: bd@aquigenbio.com
Visit: www.aquigenbio.com

About Aquigen Bio Sciences
Aquigen Bio Sciences is at the forefront of pharmaceutical excellence, serving as the leading resource for Gefitinib impurity standards in India. With a strong commitment to safety, innovation, and regulatory compliance, the organization specializes in impurity profiling, synthesis, and analysis, empowering pharmaceutical manufacturers globally with premier standards. Aquigen Bio Sciences' dedication to cutting-edge research ensures it remains a trusted partner in refining quality benchmarks across the pharmaceutical landscape.

This release was published on openPR.